54147 Efficacy of Ruxolitinib Cream for Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Baseline Clinical Characteristics: Subgroup Analysis From a Randomized Phase 3 Study (TRuE-AD3)
Recommended Citation
Armstrong AW, Eichenfield LF, Lee LW, Brar KK, Joyce JC, Forman SB, Soong W, Sofen H, Angel B, Li Q, Stein-Gold L. 54147 Efficacy of Ruxolitinib Cream for Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Baseline Clinical Characteristics: Subgroup Analysis From a Randomized Phase 3 Study>(TRuE-AD3). J Am Acad Dermatol 2024; 91(3):AB199.
Document Type
Conference Proceeding
Publication Date
9-1-2024
Publication Title
J Am Acad Dermatol
Abstract
Background: Atopic dermatitis (AD), a highly pruritic inflammatory skin disease, typically begins in childhood and affects up to 23% of children globally. Ruxolitinib cream was effective and well tolerated in adults/adolescents (TRuE-AD1/TRuE-AD2 [NCT03745638/NCT03745651]) and children 2–<12 years old (y/o; TRuE-AD3 [NCT04921969]). Here, efficacy by baseline clinical characteristics in children 2–<12 y/o enrolled in TRuE-AD3 is reported. Methods: Patients 2–<12 y/o with AD for ≥3 months, Investigator’s Global Assessment (IGA) score of 2/3, and 3%–20% affected body surface area (BSA) were randomized (2:2:1) to apply twice-daily ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks. Results: Patients 2–<12 y/o (N=330) had a median (range) age of 6 (2–11) years; AD duration, 4.8 (0.3–11.3) years; mean (SD) affected BSA was 10.5% (5.40%). At Week 8, 49/134 (36.6%) children applying 0.75% ruxolitinib cream and 74/131 (56.5%) applying 1.5% ruxolitinib cream vs 7/65 (10.8%) applying vehicle achieved IGA treatment success (IGA-TS; score 0/1 with ≥2-grade improvement from baseline); 69/134 (51.5%) and 88/131 (67.2%) vs 10/65 (15.4%) achieved ≥75% improvement in Eczema Area and Severity Index (EASI75), respectively. IGA-TS was observed regardless of baseline AD severity measure. For IGA-TS: IGA score of 2 and 3, 32.3%/48.4% vs 0% and 37.9%/59.0% vs 14.3%, respectively; EASI score ≤7 and >7, 41.7%/58.8% vs 17.2% and 30.6%/55.0% vs 5.6%. Ruxolitinib cream was well tolerated; no serious treatment-emergent adverse events were reported. Conclusions: Ruxolitinib cream is a well-tolerated and effective treatment for AD in children 2–<12 y/o, independent of baseline clinical characteristics.
Volume
91
Issue
3
First Page
AB199
